Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases

Summary What is known and objective Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database. Methods We used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis. Results and discussion The crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the